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H.R. 8299

To allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan.

This bill allows changes to be made to medical devices without the need for supplemental applications or premarket notifications if the changes are made in accordance with a predetermined change control plan.

Referred to the House Committee on Energy and Commerce.

Rep. Bilirakis, Gus M. [R-FL-12](R-FL)Sponsor
7 cosponsors6 D1 R
7cosponsors1committees3actions1related bills
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To allow for devices with a predetermined change control plan to be marketed without submi… — Informed